The FDA has approved anifrolumab-fnia (Saphnelo – AstraZeneca), a type I interferon receptor antagonist, for IV treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard treatment. Anifrolumab has not been studied in patients with severe active lupus nephritis or severe active CNS lupus. It is the first type I interferon receptor antagonist to become available in the US.

Toripalimab-tpzi (Loqtorzi – Coherus Biosciences), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin and gemcitabine for first-line treatment of recurrent locally advanced or metastatic nasopharyngeal carcinoma and for use as monotherapy for treatment of recurrent unresectable or metastatic nasopharyngeal carcinoma in adults with disease progression on or after platinum-based chemotherapy. It is the first immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma.

Since 2007, antimicrobial prophylaxis for dental procedures has been recommended to prevent viridans group streptococcal infective endocarditis only for patients at highest risk of an adverse outcome. Limiting use to such patients does not appear to have led to an increased incidence of infective endocarditis or increased mortality due to infective endocarditis.

Emrosi (Journey), an oral, low-dose, biphasic-release formulation of the tetracycline antibiotic minocycline, has been approved by the FDA for once-daily treatment of inflammatory lesions of rosacea (papules and pustules) in adults. Low-dose, biphasic-release doxycycline (Oracea, and generics) has been available for years for treatment of papulopustular rosacea.

Telavancin (Vibativ - Astellas and Theravance), a lipoglycopeptide derivative of vancomycin (Vancocin, and others), has received FDA approval for treatment of complicated skin and skin structure infections caused by susceptible gram-positive bacteria in adults.

The FDA has approved the interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) for treatment of moderate to severe plaque psoriasis in adults. Risankizumab is the third IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) and tildrakizumab (Ilumya) were approved earlier.

Acrivastine/Pseudoephedrine (Semprex-D) for Seasonal Allergic Rhinitis (Burroughs-Wellcome), a combination of acrivastine with pseudoephedrine hydrochloride, has been approved by the US Food and Drug Administration for treatment of seasonal allergic rhinitis. Acrivastine is a new H 1 -receptor antagonist with a chemical structure similar to that of triprolidine (Actidil, and others) (RN Brogden and D McTavish, Drugs, 41:927, 1991). Pseudoephedrine is an α -adrenergic agonist. The combination is available only by prescription.

Cetirizine (Zyrtec - Pfizer), a histamine H 1 -receptor antagonist, has been approved by the US Food and Drug Administration for treatment of seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria in adults and children more than 12 years old.

Insulin Glargine (Lantus) is a new long-acting human insulin analog approved by the FDA for treatment of both type 1 and type 2 diabetes. Synthesized by recombinant DNA technology, it differs from human insulin at position 21 in the A-chain where asparagine is replaced by glycine and at the C-terminus of the B-chain where two arginines are added.

Montelukast (Singulair - Merck), a leukotriene receptor antagonist already marketed for asthma (Treatment Guidelines from The Medical Letter 2002; 1:11), has been approved by the FDA for treatment of seasonal allergic rhinitis in adults and children more than 2 years old.